Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- frequency of metabolic acidosis
研究概览
简要总结
Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants.
Two different compositions are tested, main difference is in electrolyte composiiton.
详细描述
Two groups each consisting of 15 infants with a birth weight below 2000g are studied.randomization is startified by three birth weigth classes (<1000g, 1000-1500g,1500 - 2000g) human milk fortifier is introduced in two steps after oral feeding is achieved. two acid-base status and electrolyte concentrations are measured. when metabolic acidosis, defined as BE < -6 mmol/l, occurs fortifier feeding is stopped, and after a wash-out period of three days the alternative product is used.again, occurence of metabolic acidosis, need for oral bicarbonate and effect on longitudinal growth an weight gain are registered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 10 Days 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •growing premature infants with a birth weight < 2000g
排除标准
- •congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation
结局指标
主要结局
frequency of metabolic acidosis
次要结局
- need for oral bicarbonate administartion
- longitudinal growth
- weight gain
- amino acid levels in plasma an urine